Hand Sanitizer
NDC Package 78153-000-08

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Hand Sanitizer is wet hands thorouughly with product and allow to dry without wiping / for children under 6, use only under adult supervision/ not recommended for infacts. Marketed by Quimi Clean, this product is identified by NDC 78153-000 and is authorized under FDA application part333E.

Identification & Billing

NDC Package Code
78153-000-08
Package Description
240 mL in 1 BOTTLE
Product Code
78153-000
11-Digit Billing Format
78153000008
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Hand Sanitizer
Dosage Form
-
Usage Information
Wet hands thorouughly with product and allow to dry without wiping / for children under 6, use only under adult supervision/ not recommended for infacts

Regulatory & Marketing

Labeler Name
Quimi Clean
FDA Application #
part333E
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
05-15-2020
Listing Expiration
12-31-2021
Exclude Flag
I
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (78153-000). Click a package code to view its specific billing and regulatory data.

78153-000-13
400 mL in 1 BOTTLE
78153-000-19
580 mL in 1 BOTTLE

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 78153-000-08 identifies a specific commercial package of 240 ml in 1 bottle of Hand Sanitizer, labeled by Quimi Clean. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Quimi Clean on May 15, 2020. The current certification is valid through December 31, 2021.

How is this Quimi Clean product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78153000008. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
78153-000-08
11-Digit CMS (5-4-2)
78153-0000-08

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.